FDA Issues Public Health Advisory On Vioxx As Its Manufacturer Voluntarily Withdraws The Product

Date:

October 6, 2004

Source:

U.S. Food And Drug Administration

Summary:

The Food and Drug Administration (FDA) today acknowledged the voluntary withdrawal from the market of Vioxx (chemical name rofecoxib), a non-steroidal anti-inflammatory drug (NSAID) manufactured by Merck & Co. FDA today also issued a Public Health Advisory to inform patients of this action and to advise them to consult with a physician about alternative medications.

Share:

Total shares:

FULL STORY

September 30, 2004 -- The Food and Drug Administration (FDA) today acknowledged the voluntary withdrawal from the market of Vioxx (chemical name rofecoxib), a non-steroidal anti-inflammatory drug (NSAID) manufactured by Merck & Co. FDA today also issued a Public Health Advisory to inform patients of this action and to advise them to consult with a physician about alternative medications.

Merck is withdrawing Vioxx from the market after the data safety monitoring board overseeing a long-term study of the drug recommended that the study be halted because of an increased risk of serious cardiovascular events, including heart attacks and strokes, among study patients taking Vioxx compared to patients receiving placebo. The study was being done in patients at risk of developing recurrent colon polyps.

"Merck did the right thing by promptly reporting these findings to FDA and voluntarily withdrawing the product from the market," said Acting FDA Commissioner Dr. Lester M. Crawford. "Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo."

Dr. Crawford added that FDA will closely monitor other drugs in this class for similar side effects. "All of the NSAID drugs have risks when taken chronically, especially of gastrointestinal bleeding, but also liver and kidney toxicity. They should only be used continuously under the supervision of a physician."

FDA approved Vioxx in 1999 for the reduction of pain and inflammation caused by osteoarthritis, as well as for acute pain in adults and for the treatment of menstrual pain. It was the second of a new kind of NSAID (Cox-2 selective) approved by FDA. Subsequently, FDA approved Vioxx to treat the signs and symptoms of rheumatoid arthritis in adults and children.

At the time that Vioxx and other Cox-2 selective NSAIDs were approved, it was hoped that they would have a lower risk of gastrointestinal ulcers and bleeding than other NSAIDs (such as ibuprofen and naproxen). Vioxx is the only NSAID demonstrated to have a lower rate of these side effects.

Merck contacted FDA on September 27, 2004, to request a meeting and to advise the agency that the long-term study of Vioxx in patients at increased risk of colon polyps had been halted. Merck and FDA officials met the next day, September 28, and during that meeting the company informed FDA of its decision to remove Vioxx from the market voluntarily.

In June 2000, Merck submitted to FDA a safety study called VIGOR (Vioxx Gastrointestinal Outcomes Research) that found an increased risk of serious cardiovascular events, including heart attacks and strokes, in patients taking Vioxx compared to patients taking naproxen. After reviewing the results of the VIGOR study and other available data from controlled clinical trials, FDA consulted with its Arthritis Advisory Committee in February 2001 regarding the clinical interpretation of this new safety information. In April 2002, FDA implemented labeling changes to reflect the findings from the VIGOR study. The labeling changes included information about the increase in risk of cardiovascular events, including heart attack and stroke.

Recently other studies in patients taking Vioxx have also suggested an increased risk of cardiovascular events. FDA was in the process of carefully reviewing these results, to determine whether further labeling changes were warranted, when Merck informed the agency of the results of the new trial and its decision to withdraw Vioxx from the market.

U.S. Food And Drug Administration. "FDA Issues Public Health Advisory On Vioxx As Its Manufacturer Voluntarily Withdraws The Product." ScienceDaily. ScienceDaily, 6 October 2004. <www.sciencedaily.com/releases/2004/10/041006084449.htm>.

U.S. Food And Drug Administration. (2004, October 6). FDA Issues Public Health Advisory On Vioxx As Its Manufacturer Voluntarily Withdraws The Product. ScienceDaily. Retrieved August 2, 2015 from www.sciencedaily.com/releases/2004/10/041006084449.htm

U.S. Food And Drug Administration. "FDA Issues Public Health Advisory On Vioxx As Its Manufacturer Voluntarily Withdraws The Product." ScienceDaily. www.sciencedaily.com/releases/2004/10/041006084449.htm (accessed August 2, 2015).

July 31, 2015  School is just around the corner, which means backpacks and packed lunches await your children. One expert offers tips for parents to promote healthy dental habits while away from ... read more

July 29, 2015  By blocking the expression of a certain gene in patients, researchers have contributed to the demonstration of great decreases in the concentration of triglycerides in their ... read more

July 29, 2015  Viewing aquarium displays led to noticeable reductions in blood pressure and heart rate, a research team found in the first study of its kind. They also noted that higher numbers of fish helped to ... read more

May 27, 2014  The agency charged to protect patients from dangerous drug side effects needs to be more vigilant when it comes to medications that affect blood pressure. A clinical professor of family medicine has ... read more

June 6, 2013  A 2012 law that loosened conflict-of-interest restrictions for FDA advisory panels could weaken the agency's review system and could allow more drugs with safety problems to gain market ... read more

Aug. 6, 2012  Many people have probably heard of off-label drug use, but they may not know when that applies to prescriptions they are taking, a new analysis found. Off-label drug use occurs when a physician ... read more

Feb. 22, 2011  New research shows that medications which have raised safety concerns over heart attack and stroke risks may not have gotten approval from the US Food and Drug Administration if the cardiovascular ... read more